Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Interferon beta-1a

• Registration Number: NCT01074593
• Lead Sponsor: Azidus Brasil

Brief Summary

The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics).

Detailed Description

Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.

Study Timeline

• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Accepted Informed Consent
2. Study subjects male, aged 18 to 50 years;
3. Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
4. Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.

Exclusion Criteria

1. Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
2. Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
3. Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study;
4. Have been hospitalized for any reason, up to 8 weeks before the start of the study;
5. Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
6. Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
7. To present the pressure of any etiology requiring pharmacological treatment;
8. Display history of myocardial infarction, angina and / or heart failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Comparator - Merck Serono	Interferon beta-1a	Merck Serono - Interferon beta-1a
Test	Interferon beta-1a	Bergamo - Interferon beta-1a

Primary Outcome Measures

Name	Time	Method
Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.	168 hours	Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification

Secondary Outcome Measures

Name	Time	Method
Security: observation of adverse effects	168 hours

Trial Locations

Locations (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda; 🇧🇷 Valinhos, SP, Brazil